Trial · NCT04460560
Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)
NCT04460560, Phase 3, Completed, University of Pennsylvania; results first posted 2024-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE). Trials, record NCT04460560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04460560
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)
- NCT number
- NCT04460560
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Hepatorenal Syndrome
- Interventions
- Terlipressin
- First posted
- 2020-07-07
- Last updated
- 2024-10-09
- Results first posted
- 2024-10-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement of Renal Function (SCr) From Day 1 Thru End of Treatment, Repeated Measure Analysis. SCr Will be Collected Daily, From Day 1 Thru End of Treatment. Baseline SCr Will Also be Entered. | 14 days or reversal of HRS-AKI, whichever occur first | SCr will be collected daily, from Day 1 thru end of treatment. Complete response (CR) defined as ≥30% decrease in SCr with EOT SCr≤1.5, partial response (PR) as ≥30% decrease in SCr with EOT SCr\>1.5, and non-response (NR) as \<30% decrease in SCr. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Improvement of Renal Function (SCr) From Day 1 Thru End of Treatment, Repeated Measure Analysis. SCr Will be Collected Daily, From Day 1 Thru End of Treatment. Baseline SCr Will Also be Entered. | 14 days or reversal of HRS-AKI, whichever occur first | descriptive statistics were used only | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Improvement of Renal Function (SCr) From Day 1 Thru End of Treatment, Repeated Measure Analysis. SCr Will be Collected Daily, From Day 1 Thru End of Treatment. Baseline SCr Will Also be Entered. | Open-label Terlipressin | complete response | 32 | Participants | |
| Improvement of Renal Function (SCr) From Day 1 Thru End of Treatment, Repeated Measure Analysis. SCr Will be Collected Daily, From Day 1 Thru End of Treatment. Baseline SCr Will Also be Entered. | Open-label Terlipressin | partial response | 8 | Participants | |
| Improvement of Renal Function (SCr) From Day 1 Thru End of Treatment, Repeated Measure Analysis. SCr Will be Collected Daily, From Day 1 Thru End of Treatment. Baseline SCr Will Also be Entered. | Open-label Terlipressin | no response | 10 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prospective Terlipressin Group | 50 | |
| Overall Study | COMPLETED | Prospective Terlipressin Group | 50 | |
| Overall Study | NOT COMPLETED | Prospective Terlipressin Group | 0 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hypotension | Nervous system disorders | Open-Label Terlipressin | 3 | 50 | 3 |
| serious | AKI | Renal and urinary disorders | Open-Label Terlipressin | 9 | 50 | 9 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Open-Label Terlipressin | 1 | 50 | 1 |
| serious | Altered Mental Status (including hepatic encephalopathy) | Nervous system disorders | Open-Label Terlipressin | 6 | 50 | 6 |
| serious | Electrolyte abnormality | Renal and urinary disorders | Open-Label Terlipressin | 2 | 50 | 2 |
| serious | Abdominal pain | Gastrointestinal disorders | Open-Label Terlipressin | 3 | 50 | 3 |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Open-Label Terlipressin | 1 | 50 | 1 |
| serious | Multi Organ Failure | General disorders | Open-Label Terlipressin | 1 | 50 | 1 |
| serious | Gastrointestinal Bleed | Gastrointestinal disorders | Open-Label Terlipressin | 1 | 50 | 1 |
| serious | Spontaneous Bacterial Peritonitis | Infections and infestations | Open-Label Terlipressin | 2 | 50 | 2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-Label Terlipressin | 14 | 50 |
| Total, other adverse events | Open-Label Terlipressin | 0 | 50 |
| Total, serious adverse events | Open-Label Terlipressin | 26 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04460560
GET https://conductscience.org/api/trials/v1/NCT04460560/registered